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Medical Device & Cosmetics Importing Services

Ensure FDA Compliance for Your Medical Devices & Cosmetics Imports

Importing medical devices and cosmetics into the U.S. requires strict compliance with FDA regulations. Our expert team helps you navigate registration, labeling, and safety requirements to ensure smooth entry into the U.S. market.

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Medical Device & Cosmetics Importing Services

The FDA regulates medical devices and cosmetics to ensure consumer safety and product efficacy. From facility registration to labeling compliance, every step must align with federal regulations to avoid import holds, delays, or product rejections. Our specialized team provides tailored solutions to simplify compliance, helping you bring your products to market faster while minimizing regulatory risks.

Whether you’re importing medical devices, skincare, beauty products, or over-the-counter (OTC) cosmetics, we ensure full FDA compliance every step of the way.

Medical Device Listing & Classification Support

Medical devices must be properly classified and listed with the FDA before being marketed in the U.S. Our experts guide you through classification and regulatory submission to avoid compliance issues.

  • Identification of correct device classification (Class I, II, or III)
  • Preparation and submission of FDA device listings
  • Assistance with 510(k) premarket notification (if required)
  • Compliance verification for low-risk exempt devices
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FDA Establishment Registration for Medical Device & Cosmetic Facilities

All U.S. and foreign manufacturers, distributors, and repackers of medical devices and certain cosmetic products must register their establishments with the FDA. We handle the registration process to ensure your compliance.

  • FDA Establishment Registration submission assistance
  • FDA registration biennial renewal tracking and updates
  • U.S. Agent representation for foreign companies
  • Compliance monitoring for regulatory changes
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510(k) Premarket Notification for Medical Devices

Certain Class II medical devices require a 510(k) premarket notification to demonstrate substantial equivalence to an already marketed device. We assist with preparation and submission to ensure compliance.

  • Determination of whether your device requires a 510(k) submission
  • Preparation and filing of required FDA documentation
  • Support in demonstrating substantial equivalence to a legally marketed device
  • Regulatory guidance throughout the review process
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Cosmetic Labeling Compliance & Ingredient Review

The FDA has strict labeling and ingredient regulations for cosmetic products, especially for products containing color additives, drug claims, or restricted substances. We will review your labels and formulations to ensure full compliance.

  • Label review for all required FDA elements
  • Verification of ingredient safety and compliance with FDA regulations
  • Guidance on permissible claims (e.g., avoiding drug claims)
  • Compliance with packaging regulations for imported cosmetics
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FSVP Agent Services for Medical Device & Cosmetic Importers

Under the Foreign Supplier Verification Program (FSVP), importers of certain medical devices and cosmetic products must verify that their foreign suppliers meet U.S. regulatory standards. As your designated FSVP Agent, we manage this process on your behalf.

  • Acting as your official FSVP Agent for FDA compliance
  • Supplier compliance verification and documentation
  • FDA audit support and regulatory reporting
  • Ongoing monitoring of supplier compliance status
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Good Manufacturing Practice for Medical Devices & Cosmetics

Manufacturers of medical devices and certain cosmetics must comply with Good Manufacturing Practice (GMP) regulations under 21 CFR Part 820 (for devices) and 21 CFR Part 700 (for cosmetics). We help ensure compliance to maintain product safety and quality.

  • GMP compliance audits and assessments done by qualified PCQI's
  • Quality control procedures and documentation review
  • Corrective action planning for regulatory deficiencies
  • Supplier qualification and verification
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Global Import Agent

Why Choose Global Import Agent?

Global trade in food and beverages is fraught with strict regulations and potential pitfalls. Our team of experts ensures your imports meet FDA and USDA requirements with precision, speed, and reliability. From compliance documentation to navigating permits and certifications, we provide comprehensive solutions tailored to your needs. Trust us to safeguard your operations and streamline your importing process, giving you the peace of mind to focus on your business goals.

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. Do I need to register my medical device or cosmetic facility with the FDA?

Yes. All manufacturers, repackers, and distributors of medical devices must register their facilities annually. Cosmetic facilities are not required to register unless they manufacture OTC (over-the-counter) products or use restricted ingredients.

 

Q. What is a 510(k) premarket notification, and does my medical device need one?

A 510(k) is a premarket submission required for certain Class II medical devices to demonstrate that the device is substantially equivalent to an already legally marketed device. Not all devices require a 510(k) submission, but we can help determine if yours does.

 

Q. What are FDA labeling requirements for cosmetics?

Cosmetic labels must include:

  • Identity statement (product name)
  • Net quantity of contents
  • Ingredient list in descending order
  • Name and address of the manufacturer or distributor
  • Required warnings (if applicable)

Additionally, cosmetic products cannot contain drug claims (e.g., “treats acne”) without being classified as an over-the-counter drug.

Q. Can my cosmetic product contain color additives?

Only FDA-approved color additives are allowed in cosmetics. Certain colors require batch certification, and others may only be used in specific types of products (e.g., eye-area products). We review formulations to ensure compliance.

Q. What happens if my medical device or cosmetic product is detained by the FDA?

If your product is detained, we can assist in:

  • Identifying the cause of the detention
  • Communicating with the FDA and Customs
  • Preparing necessary documentation for release
  • Implementing corrective actions to prevent future detentions

Q. What are the main reasons medical devices and cosmetics are refused entry into the U.S.?

Products may be refused entry due to:

  • Missing or incorrect FDA registration
  • Non-compliant labeling or packaging
  • Unauthorized ingredients or restricted substances
  • GMP violations or poor manufacturing practices

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